Evaluating the effectiveness and safety of Synergy XD and Megatron stents
Evaluation of Effectiveness and Safety of Synergy™ XD Stent and Synergy Megatron™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Asan Medical Center · NCT05044273
This study is testing how well and safely the Synergy XD and Megatron stents work for people with coronary artery disease compared to other stents in real-life situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center (other) |
| Locations | 23 sites (Anyang and 22 other locations) |
| Trial ID | NCT05044273 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness and safety of the Synergy XD and Synergy Megatron™ stents in real-world clinical practice. It is a non-randomized, prospective, open-label registry that compares these stents against other drug-eluting stents in patients diagnosed with coronary artery disease. Participants will be monitored for outcomes related to their stent treatment, providing valuable data on performance in everyday settings.
Who should consider this trial
Good fit: Ideal candidates include patients aged 19 and older who are receiving either the Synergy XD or Synergy Megatron™ stents.
Not a fit: Patients with a mixture of other drug-eluting stents, terminal illnesses, or those in cardiogenic shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with coronary artery disease.
How similar studies have performed: Other studies have shown success with similar drug-eluting stent evaluations, indicating a foundation for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 19 years old * Patients receiving Synergy XD stent(s) or Synergy Megatron™ stent(s). * The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site. Exclusion Criteria: * Patients with a mixture of other drug-eluting stents (DESs) * Terminal illness with life-expectancy ≤1 year. * Patients with cardiogenic shock
Where this trial is running
Anyang and 22 other locations
- Hallym University Medical Center — Anyang, South Korea (RECRUITING)
- Dong-A University Hospital — Busan, South Korea (RECRUITING)
- Inje University Busan Paik Hospital — Busan, South Korea (TERMINATED)
- Inje university Pusan Paik hospital — Busan, South Korea (RECRUITING)
- Pusan National University Hospital — Busan, South Korea (TERMINATED)
- Pusan National University Hospital — Busan, South Korea (RECRUITING)
- Pusan National University Yangsan Hospital — Busan, South Korea (RECRUITING)
- Gyeongsang National University Changwon Hospital — Changwon, South Korea (RECRUITING)
- Samsung Changwon Hospital — Changwon, South Korea (RECRUITING)
- Keimyung University Dongsan Medical Center — Daegu, South Korea (RECRUITING)
- Veterans Hospital — Daegu, South Korea (RECRUITING)
- Yeungnam University Medical Center — Daegu, South Korea (RECRUITING)
- Gangneung Asan Hospital — Gangneung, South Korea (RECRUITING)
- Chonnam National University Hospital — Gwangju, South Korea (RECRUITING)
- Wonkwang University Hospital — Iksan, South Korea (RECRUITING)
- CHA Bundang Medical Center, CHA University — Seongnam, South Korea (TERMINATED)
- Seoul university Bundang hospital — Seongnam, South Korea (RECRUITING)
- Asan Medical Center — Seoul, South Korea (RECRUITING)
- Hanyang University Seoul Hospital — Seoul, South Korea (RECRUITING)
- Korea University Anam Hospital — Seoul, South Korea (RECRUITING)
- Korea University Guro Hospital — Seoul, South Korea (TERMINATED)
- The Catholic University of Korea, ST. Vincent's Hospital — Suwon, South Korea (RECRUITING)
- Ulsan University Hospital — Ulsan, South Korea (RECRUITING)
Study contacts
- Study coordinator: Jung-hee Ham, Project Manager
- Email: cvcrc5@amc.seoul.kr
- Phone: 82230104728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Coronary Disease, drug eluting stent, percutaneous coronary intervention, real world